• First and only anti-CD38 anti­body in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone (pom-dex) to be approved in Canada^1,2
• SARCLISA™ in com­bi­na­tion with pom-dex sig­nif­i­cantly reduced the risk of dis­ease pro­gres­sion or death by 40% com­pared to pom-dex alone in a pivotal trial²
• Multiple myeloma is the third most common blood cancer in Canada³

Mississauga, ON (Press Release) – Sanofi Canada is pleased to an­nounce that Health Canada has approved SARCLISA™ in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone for the treat­ment of adults with re­lapsed and re­frac­tory mul­ti­ple myeloma (RRMM) who have re­ceived at least two prior ther­a­pies in­clud­ing lena­lido­mide and a pro­te­a­some in­hib­i­tor.²

"Immunotherapies like SARCLISA™ leverage the im­mune sys­tem to fight mul­ti­ple myeloma and we're seeing real progress in their ability to help patients. This was not the case over a decade ago," says Dr. Donna Reece, Clinician In­ves­ti­ga­tor, Princess Margaret Cancer Centre.

SARCLISA™ binds to a spe­cif­ic extracellular epitope of CD38 and triggers sev­er­al mech­a­nisms lead­ing to the death of CD38-expressing tumour cells.²

"For Canadian patients living with mul­ti­ple myeloma, who have ex­peri­enced a return of their dis­ease or be­come re­sis­tant to prior treat­ments, it's vital to have new op­tions like SARCLISA™," says Marissa Poole, Country Lead, Canada and General Manager, Sanofi Genzyme. "At Sanofi Genzyme we re­main com­mit­ted to devel­op­ing inno­va­tive med­i­cines that can make a sig­nif­i­cant dif­fer­ence in patients' lives. SARCLISA™ has the po­ten­tial to offer a new standard of care, and we con­tinue to eval­u­ate SARCLISA™ in a com­pre­hen­sive clin­i­cal pro­gram in mul­ti­ple myeloma, as well as in other blood cancers and solid tumours."

Multiple Myeloma Leads to Significant Burden of Disease

Every day, 9 Canadians are diag­nosed with mul­ti­ple myeloma, a cancer of the blood in which ab­nor­mal plasma cells in­ter­fere with nor­mal, healthy blood cell pro­duc­tion and function. The cause is un­known and there is no cure.⁴

"We en­cour­age patients to play an active role in treat­ment de­ci­sions. But every patient is dif­fer­en­t – their life goals, their dis­ease, the care they re­quire. We must con­tinue to advocate for them and im­prove their access to the ther­a­pies they need," says Martine Elias, Executive Director, Myeloma Canada. "The re­search in myeloma has been promising. We're seeing new ther­a­pies, like SARCLISA™, becoming avail­able to more patients. Every new treat­ment is a move in the right di­rec­tion to help patients live longer and better lives and con­tinue to de­liver hope."

Relapsed (or re­cur­rent) mul­ti­ple myeloma means that the cancer returns after treat­ment or a period of remission. Since mul­ti­ple myeloma does not have a cure, most patients will relapse at some point. Re­frac­tory mul­ti­ple myeloma refers to cancer that does not respond to ther­apy.⁵

About SARCLISA™

The ap­prov­al of SARCLISA™ by Health Canada was based on the ICARIA-MM study.6 SARCLISA™ added to pom-dex (SARCLISA com­bi­na­tion ther­apy) dem­onstrated a statistically sig­nif­i­cant im­prove­ment in pro­gres­sion-free sur­vival (PFS) with a median PFS of 11.5 months com­pared to 6.5 months with pom-dex alone (HR 0.596, 95% CI: 0.44-0.81, p=0.0010).^2,6 SARCLISA™ com­bi­na­tion ther­apy also dem­onstrated a sig­nif­i­cantly greater over­all re­sponse rate com­pared to pom-dex alone (60.4% vs. 35.3%, p<0.0001).²

The most common adverse reac­tions (occurring in >20% of patients) in patients who re­ceived SARCLISA™ com­bi­na­tion ther­apy were in­fusion-related reac­tions (38%), pneu­monia (31%), upper res­pira­tory tract in­fec­tions (28%) and diarrhea (26%).² Abnormal hema­to­logical laboratory re­­sults were evident in patients who re­ceived SARCLISA™ com­bi­na­tion ther­apy, in­clud­ing neu­tro­penia (96%) and febrile neu­tro­penia (12%).^2,6 Permanent dis­con­tinu­a­tion of SARCLISA™ com­bi­na­tion ther­apy due to an adverse reac­tion (Grades 3-4) oc­curred in 7% of patients, and 3% of patients dis­con­tinued due to an in­fusion-related reac­tion.²

SARCLISA™ is to be admin­istered as an in­tra­venous (IV) in­fusion at 10 mg/kg, in com­bi­na­tion with pom-dex, every week for four weeks and then every two weeks, until dis­ease pro­gres­sion or un­ac­cept­able toxicity.²

SARCLISA™ con­tinues to be eval­u­ated in mul­ti­ple on­go­ing Phase 3 clin­i­cal trials.

About Sanofi

Life is a health journey and we, at Sanofi, are com­mit­ted to finding thera­peutic solu­tions for the mil­lions of people who are or will be con­cerned by cancer. The num­ber of cancer cases is ex­pected to grow dramatically over the next two decades.

As a health journey part­ner, we, at Sanofi, are rising to the chal­lenge. We are com­mit­ted to fighting cancer through early detection and treat­ments, in­clud­ing pain relief and palliative care. Sanofi Genzyme, our global spe­cial­ty care business unit, has inno­va­tive treat­ments under de­vel­op­ment and is exploring inno­va­tive path­ways to fight cancer.

References

1. Data on file. Sanofi Genzyme.
2. ^PrSARCLISA™ Product Monograph. Sanofi Genzyme. April 29, 2020.
3. Canadian Cancer Statistics Advisory Com­mit­tee. Canadian Cancer Statistics 2019. Toronto, ON: Canadian Cancer Society; 2019. Available at: cancer.ca/Canadian-Cancer-Statistics-2019-EN (accessed 8 June 2020).
4. Myeloma Canada. Available at: https://www.myelomacanada.ca/en/about-multiple-myeloma/what-is-myeloma (accessed 27 May, 2020).
5. National In­sti­tutes of Health. National Cancer In­sti­tute Dictionary of Cancer Terms. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms/search (accessed 8 June 2020).
6. Attal M, Richardson PG, Rajkumar SV, et al. Isatuximab plus poma­lido­mide and low-dose dexa­meth­a­sone versus poma­lido­mide and low-dose dexa­meth­a­sone in patients with re­lapsed and re­frac­tory mul­ti­ple myeloma (ICARIA-MM): a ran­domised, multicentre, open-label, phase 3 study. Lancet Oncol. 2019; 394: 2096–107. doi:10.1016/S0140-6736(19)32556-5.

Source: Sanofi Canada.